Regulatory Affairs, Quality Assurance

*** ****** *****, ********* ***, PA ***** 724-***-**** *******@************.***

Erica L. Nicoll

Objective

To obtain a position in Regulatory Affairs/Quality Assurance, utilizing my knowledge and experience with FDA laws and regulations, and GxP compliance Experience

10/2013 – present Novum Pharmaceutical Research Services Pittsburgh, PA Regulatory Compliance Specialist

Conduct mock FDA inspections, assure GxP compliance with regulatory requirements for internal processes and vendor audits, and perform risk analysis of ongoing projects

Act as a liaison with Regulatory Authorities during Regulatory Authority inspections, maintain the status of inspectional findings, and assist in corrective action plans, as appropriate

Lead multi-department team responsible for responding to Regulatory Authority inquiries, and perform tracking/trending analysis of requests

Develop and administer training on regulations, GCP, and compliance programs to team members across the organization

Monitor FDA and other applicable industry regulatory and compliance trends and provide updates to management

Review SOPs for regulatory compliance and author departmental work instructions

Ensure licensing, certifications, and regulatory requirements are complete/up to date 10/2002 – 10/2013 U.S. Food and Drug Administration Pittsburgh, PA Consumer Safety Officer

Conducted regulatory establishment inspections of various regulated industries for compliance with the FD&C Act and the PHS Act, and prepared written establishment inspection reports for each firm inspected

Directed and managed teams for complex establishment inspections. Acted as the spokesperson for the team in discussions with the Compliance Branch, CFSAN, Office of Enforcement, Office of Chief Council, and Office of Criminal Investigations.

Collaborated with other law enforcement including the FDA’s Office of Criminal Investigations and the U.S. Marshals Service

Developed and administered training presentations for newly hired investigators. Mentored new hire investigators and evaluated training needs. Developed, organized, and provided on-the-job training.

Provided presentations at a conference jointly sponsored by FDA and the Society of Clinical Research Associates

Compliance Officer

Reviewed inspection reports and prepared Recommendation Memo and draft Warning Letter for submission to FDA Centers

Reviewed import entries and determined whether the entry would be detained, released, or refused.

Acted as a liaison to importers and brokers regarding the status of the import entry 724-***-**** *******@************.***

Erica L. Nicoll

Supervisory Consumer Safety Officer

Responsible for a group of Consumer Safety Officers, Consumer Safety Investigator, and Consumer Safety Technician

Managed the BIMO Program for the District

Responsible for work planning, performance evaluations, and individual development plans Quality Systems Manager

Participated in regional Quality Systems Managers meetings to discuss ongoing projects and goals for the Central Region

Coordinated with the Investigations and Compliance Branches on a project to determine a timeline for updating SOPs, identify auditors and an auditing schedule, and create a sampling plan for work product review

Education

06/2010 – 12/2011 The Johns Hopkins University Baltimore, MD M.S. Biotechnology

Concentration in Regulatory Affairs

08/1998 – 05/2002 The Pennsylvania State University University Park, PA B.S. Chemistry

Minor in General Business

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